Context : Export Ban on Tapentadol-Carisoprodol Combinations
- Health Ministry banned the export of unapproved combination drugs containing Tapentadol and Carisoprodol.
- Action taken after reports of Aveo Pharmaceuticals (Mumbai) exporting these drugs to certain West African countries.
Relevance : GS 2(Health, Governance)
Drug Profiles
- Tapentadol: Opioid used for moderate to severe pain; approved in various tablet forms (50-200 mg).
- Carisoprodol: Muscle relaxant targeting pain centers in the brain and spinal cord.
- The combination is not approved in India and not listed under the NDPS Act.
Regulatory Actions & Compliance Measures
- CDSCO and State regulators initiated risk-based inspections since December 2022:
- 905 manufacturing units inspected.
- 694 regulatory actions taken (including production halts, licence suspensions, and warnings).
- Aveo Pharmaceuticals audited (Feb 21-22); operations halted following non-compliance findings.
Seizure & Preventive Measures
- Seized materials:
- 1.3 crore tablets/capsules.
- 26 batches of Tapentadol and Carisoprodol APIs.
- Maharashtra FDA ordered immediate production stop and withdrawal of export NoCs.
- Nationwide instructions issued to prevent further distribution of the unapproved combination.
